Job Description

Job Duration: Long Term Contract (Possibility Of Extension)

Pay Rate : $42/hr on W2

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

Duration: Long term contract (Possibility of further extension)

Primary Duties:

The Quality Assurance Operations Specialist will:
• Performs work under general supervision.
• Provide quality, technical support and oversight during manufacturing activities.
• Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition.
• Open deviations as appropriate based upon Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
• Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
• Review and evaluate QC testing records and any associated OOS investigations.
• Review, write, revise, and approve SOP’s, technical documents, and reports.
• Perform inspection and release of materials used for production and review vendor certificates for completeness / compliance against approved specifications and collaborate with Material Management to release incoming materials for production.
• Compile and maintain metrics for testing results, quality documentation closure, and disposition and evaluate trending data to identify any irregular trends and notify management as required.
• Provide administrative project management support for Quality Management System integration and improvement projects.
• Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc.
• Support coordination of site Change Control Review Board and change control communications with third party license holder.
• Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials.



Education and Experience Requirements :

• Bachelor’s Degree in scientific discipline;
• Minimum of 3-5 years in a regulated manufacturing environment with exposure to Quality and Manufacturing field.
• Knowledge of Quality Systems such as Change Control, Investigations and CAPA;
• Ability to communicate effectively with wide range of personnel;
• Technical writing skills related to investigation reports.
• General working knowledge of relevant governmental regulations, cGMP and guidelines.

If interested, please send us your updated resume at

hr@dawarconsulting.com akansha@dawarconsulting.com

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